Liver Cancer Registry Platform

Cholangiocarcinoma Clinical Trial

— JADE  

Official title:

JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510740
• Other study ID #: IOM-100425
• Status: Recruiting
• Start date: August 9, 2020
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: iOMEDICO AG
• Contact: iOMEDICO AG
• Phone: +49 761 15242-0
• Email: info[@]iomedico.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Hepatocellular Carcinoma (HCC) or Cholangiocarcinoma (CCC) in Germany.

Description:

JADE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of HCC or CCC in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life in patients with HCC / CCC will be evaluated for up to three years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) als early, intermediate or advanced/metastatic stage

• Age = 18 years

• Signed and dated informed consent (IC):

• For participation in the PRO module: Before primary locoregional therapy or start of first systemic treatment

• For no participation in the PRO module: No later than 8 weeks after primary locoregional therapy or start of first systemic treatment

Exclusion criteria:

Patients treated with best supportive care (BSC) only (i.e. no surgery, no radiotherapy, no ablative procedures, no systemic anti-tumoral therapies)

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hepatocellular Carcinoma (HCC)

Intervention

Other:
• Physician's choice according to patient's needs.
Routine care as per site standard.

Locations

Country	Name	City	State
Germany	Multiple sites all over germany	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Course of treatment (treatment reality).	Documentation of anamnestic data and therapy sequences.	3 years per patient.
Secondary	Best Response.	Documentation of response rates per line of treatment.	3 years per patient.
Secondary	Progression-free survival.	Documentation of progression-free survival per line of treatment.	3 years per patient.
Secondary	Overall survival.	Documentation of overall survival per line of treatment.	3 years per patient.
Secondary	Health-related quality of life (Patient-reported outcome, PRO).	EORTC QLQ-C30 core questionnaire [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high scale score represents a higher response level: (a) global health status: a high score represents high quality of life, (b) functional scales: a high score represents high/healthy level of functioning, (c) symptom scales/items: a high score represents high level of symptomatology or problems]	3 years per patient.
Secondary	Carcinoma Health-related quality of life (Patient-reported outcome, PRO).	EORTC QLQ-HCC18, the hepatocellular carcinoma specific module / EORTC QLQ-BIL21, the cholangiocarcinoma specific module [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high score for scales and single items represents a high level of symptomatology or problems].	3 years per patient.